UDI

Bar Code Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh? Yes, if the U.S. tracked medical devices the way it’s done elsewhere. The Food and Drug Administration (FDA) is finally taking a step in that [...]

October 30, 2012 ~ The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its [...]

Public Invited to FDA meeting on Postmarket Surveillance Barcode, Wiki, author, Maly LOLek September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and [...]

August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years. On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It [...]